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Celularity Announces Sales of UltraMIST® Ultrasound Healing Therapy Asset to Sanuwave Health, Inc.

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Celularity, Inc.  (”Celularity” or “the Company”) today announced that it has sold its UltraMIST® Ultrasound Healing Therapy asset to Sanuwave Health, Inc. [OTC PNK: SNWV] (“Sanuwave”) in connection with which Celularity granted Sanuwave certain partnership rights to the Company’s wound care biologic product portfolio. The Company will continue to sell biologic products and other advanced biomaterials on a direct basis outside wound care with a focus around surgical sub-specialties. Celularity manufactures biologic products and other advanced biomaterials at its new, state of the art GMP-ready facility located in Florham Park, NJ. The Company continues to expand its biomaterial portfolio by pairing state-of-the-art manufacturing with the inherent scalability of cell therapies and biomaterials derived from the human placenta.

 

About Celularity
Celularity, headquartered in Florham Park, N.J., is a next-generation Biotechnology company leading the next evolution in cellular medicine by delivering off-the-shelf allogeneic cellular therapies, at unparalleled scale, quality, and economics. Celularity’s innovative approach to cell therapy harnesses the unique therapeutic potential locked within the cells of the post partum placenta. Through nature’s immunotherapy engine – the placenta – Celularity is leading the next evolution of cellular medicine with placental-derived T cells, NK cells, and pluripotent stem cells to target unmet and underserved clinical needs in cancer, infectious and degenerative diseases. In addition, Celularity manufactures and markets two commercial-stage products, Biovance® Human Amniotic Membrane Allograft and Interfyl® Human Connective Tissue Matrix. To learn more, please visit www.celularity.com.

Celularity announces the activation of first California Clinical Trial Site following CIRM Grant Award to Advance Treatments for COVID-19

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  • University of California Irvine is the first California site participating in Celularity’s CYNK-001-COVID-19 clinical trial NCT04365101 using Celularity’s investigational immunotherapy to treat adults who tested COVID-19 positive in underserved and disproportionately affected populations.
  • CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells.

 

Florham Park, NJ – July 29, 2020 – Celularity today announced that it has been awarded a $750,000 COVID-19 Project grant by the California Institute for Regenerative Medicine (CIRM), one of the three clinical awards targeting the coronavirus. This grant will support California Institutions participating in the Phase I/II clinical trial of human placental hematopoietic stem cell derived natural killer (NK) cells (CYNK-001) for the treatment of adults with COVID-19.  The University of California Irvine is the first CA site to open for patient enrollment.

CIRM’s COVID-19 Project supports promising discovery, preclinical and clinical trial stage projects that could quickly advance treatments or vaccines that utilize stem and/or progenitor cells. Celularity will use the CIRM grant to support the evaluation of the anti-viral activities of its cryopreserved investigational product, CYNK-001,  in underserved and disproportionately affected populations with COVID-19, an infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Celularity received clearance from the United States Food and Drug Administration to proceed with a Phase I/II study to evaluate the safety, tolerability, and efficacy of CYNK-001 in patients with COVID-19.

“Our investigational product CYNK-001 showed great promise in preclinical studies, and we are optimistic that it will prove effective against corona virus diseases, including COVID-19. As part of our rapidly-scalable placental-derived cellular medicine platform, CYNK-001 could play an important role in the public health response to outbreaks of COVID-19 or other coronaviruses,” said Robert J. Hariri, MD, PhD, Founder, Chairman and CEO of Celularity. “We are very grateful to CIRM for supporting our effort to make novel cellular medicines available to medically underserved and disproportionately affected persons in California.”

Xiaokui Zhang, PhD, Chief Scientific Officer and Principal Investigator under the CIRM grant says “CYNK-001 has a range of biological activities that not only recognize and destroy virus-infected cells, but also coordinate a robust immune response that may lead to an effective and durable defense against the viral infection.”

The trial will evaluate the safety and the clinical efficacy of CYNK-001 in SARS-CoV-2 positive subjects as measured by clearance of the SARS-CoV-2 and improvement in clinical symptoms or improvement in radiological evaluation of disease related chest x-ray.  The primary objective of the Phase I portion of the study is to evaluate the safety, tolerability, and efficacy of multiple CYNK-001 intravenous (IV) infusions in COVID-19 patients and will be administered to up to 14 patients in three doses over the course of seven days.

The Phase II portion of the study is a randomized, open-label, multi-site study measuring multiple doses of CYNK-001 against a control group experiencing a similar degree of infection with best supportive care, with two co-primary endpoints. The first co-primary endpoint is to determine the virologic efficacy of CYNK-001 in facilitating the clearance of SARS-CoV-2 from mucosal specimens and/or peripheral blood. The second co-primary endpoint is to assess the impact of treatment with CYNK-001 on clinical symptoms among patients with COVID-19 related lower respiratory tract infection.

Celularity has treated patients with severe COVID-19 and on ventilator support under compassionate use programs in U.S. CYNK-001 was well tolerated and may be associated with clinical benefit in selected cases.

 

About NK Cells

NK cells are innate immune cells with an important role in early host response against various pathogens. Multiple NK cell receptors are involved in the recognition of infected cells. Studies in humans and mice have established that there is robust activation of NK cells during viral infection, regardless of the virus class, and that the depletion of NK cells aggravates viral pathogenesis.

 

About CYNK-001

CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy developed from placental hematopoietic stem cells. CYNK-001 is being investigated as a potential treatment option in adults with COVID-19, as well as for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM). On 1 April, the U.S. Food and Drug Administration cleared the Company’s Investigational New Drug (IND) application for the use of CYNK-001 in adults with COVID-19.

 

About COVID-19

The virus causing COVID-19 is called severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and is a novel coronavirus that has not been previously identified. COVID-19 has become a global pandemic, with over 4.2 million confirmed cases in the USA and over 650,000 deaths reported to date worldwide.

 

About Celularity

Celularity, headquartered in Florham Park, N.J., is a next-generation Biotechnology company leading the next evolution in cellular medicine by delivering off-the-shelf allogeneic cellular therapies, at unparalleled scale, quality, and economics. Celularity’s innovative approach to cell therapy harnesses the unique therapeutic potential locked within the cells of the post partum placenta. Through nature’s immunotherapy engine – the placenta – Celularity is leading the next evolution of cellular medicine with placental-derived T cells, NK cells, and pluripotent stem cells to target unmet and underserved clinical needs in cancer, infectious and degenerative diseases. To learn more visit celularity.com

Celularity Expands Strategic Collaboration with United Therapeutics Corporation to COVID-19 Infection and Acute Respiratory Distress Syndrome

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WARREN, N.J., April 9, 2020 /PRNewswire/ — Celularity Inc. (“Celularity” or the “Company”), a clinical-stage company developing allogeneic cellular therapies from human placentas, today announced the expansion of its existing collaborative license agreement with United Therapeutics Corporation’s (Nasdaq: UTHR) wholly-owned subsidiary, Lung Biotechnology PBC, to include the treatment of COVID-19 and Acute Respiratory Distress Syndrome (ARDS).

This announcement builds on recent pioneering work by Celularity for the use of its proprietary CYNK-001 for the treatment of the SARS-CoV-2 virus that causes the coronavirus disease, COVID-19, and extends this application of the technology to ARDS. The U.S. Food and Drug Administration recently cleared Celularity’s investigational new drug application (IND 019650) to evaluate CYNK-001’s safety, tolerability, and efficacy for the treatment of COVID-19.

ARDS, the most devastating complication of COVID-19, is a serious inflammatory lung injury that causes hypoxemia, or below-normal oxygen level in the blood. Hypoxemia can lead to multi-organ system failure and death. Recent findings indicate that ARDS may develop in as many as 17-29% of COVID-19 patients who are hospitalized with pneumonia.

Celularity founder and Chief Executive Officer, Dr. Robert Hariri, said, “This promising, novel approach to treating COVID-19 and the pulmonary complications associated with this infection may unlock a powerful new therapeutic option for patients. The exceptional expertise in pulmonary disease, cellular medicine, and manufacturing makes this strategic collaboration particularly well suited to tackle this urgent, global medical crisis.”

Under the amended collaborative agreement, Celularity will seek regulatory approval for CYNK-001 in COVID-19, and Lung Biotechnology will seek regulatory approval for CYNK-001 in ARDS. Lung Biotechnology has global rights under the amended collaborative agreement to commercialize CYNK-001 in COVID-19 and ARDS. The collaboration will be governed by a Joint Steering Committee to oversee development and commercialization activities. Financial terms were not disclosed.

Celularity’s CYNK-001 is the only cryopreserved allogeneic, off-the-shelf Natural Killer (NK) cell therapy being developed from placental hematopoietic stem cells and is being investigated as a potential treatment option for various hematologic cancers and solid tumors, and is the first cell therapy granted an IND to treat COVID-19. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and virally infected cells and interacting with adaptive immunity. CYNK-001 cells derived from the postpartum placenta have been shown to be well-tolerated in early clinical trials and are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM).

Media and Investor Relations
Media Contact:
Factory PR
celularity@factorypr.com

Investor Relations Contact:
John R. Haines, Executive Vice President
john.haines@celularity.com

About Celularity: Celularity, headquartered in Warren, N.J., is a clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies derived from the postpartum human placenta. Using proprietary technology in combination with its IMPACT™ platform, Celularity is the only company harnessing the purity and versatility of placental-derived cells to develop and manufacture innovative and highly scalable off-the-shelf treatments for patients with cancer, inflammatory, infectious, and age-related diseases. To learn more, please visit www.celularity.com.

Forward-Looking Statements: This press release contains forward-looking statements. These forward-looking statements are based on expectations and are subject to certain factors, risks, and uncertainties that may cause actual results, the outcome of events, timing and performance to differ materially from those expressed or implied by such statements. The information contained in this press release is believed to be current as of the date of the original issue. Celularity expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

SOURCE Celularity Inc.

Celularity Announces FDA Clearance of IND Application for CYNK-001 in Coronavirus, First in Cellular Therapy

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WARREN, N.J., April 2, 2020 /PRNewswire/ — Celularity Inc. (“Celularity” or the “Company”), a clinical-stage company developing allogeneic cellular therapies from human placentas, today announced the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for the use of its proprietary CYNK-001 in adults with COVID-19. With this, Celularity will commence a Phase I/II clinical study including up to 86 patients with COVID-19. The Company believes CYNK-001 is the first immunotherapy IND cleared by the FDA to treat COVID-19 infected adults.

“This IND represents a significant step toward a potential treatment of patients infected with COVID-19 virus, which is spreading globally at unanticipated rates,” said Robert Hariri, M.D., Ph.D., Founder, Chairman and CEO at Celularity. “With our initial clinical study, we will gain an understanding of the impact CYNK-001 can have on patients recently diagnosed with COVID-19. We are hopeful to contribute to flattening the COVID-19 curve, expanding on the promising early results we’ve seen in our clinical studies in devastating cancers to patients with coronavirus.” Dr. Hariri also thanked the FDA’s Center for Biologics Evaluation and Research (CBER) in his statement, “While most of its work occurs out of the public’s eye, CBER embodies the public service ideal amidst the current crisis. Thanks to the women and men of CBER for their tireless effort to guide us through the IND process.”

CYNK-001 is the only cryopreserved allogeneic, off-the-shelf Natural Killer (NK) cell therapy being developed from placental hematopoietic stem cells and is being investigated as a potential treatment option for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. CYNK-001 cells derived from the placenta are intrinsically safe and versatile and are currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and glioblastoma multiforme (GBM).

“Studies have established that there is robust activation of NK cells during viral infection regardless of the virus class,” says Celularity’s Chief Scientific Officer, Xiaokui Zhang, PhD. “CYNK-001 demonstrates a range of biological activities expected of NK cells, including expression of activating receptors such as NKG2D, DNAM-1 and the natural cytotoxicity receptors NKp30, NKp44 and NKp46, which bind to stress ligands and viral antigens on infected cells. They also show the expression of cytolytic molecules perforin and granzyme B, which kill recognized infected cells. These functions suggest that CYNK-001 could provide a benefit to COVID-19 patients in terms of limiting SARS-CoV-2 replication and disease progression by eliminating the infected cells.”

Media Contact:
Factory PR
celularity@factorypr.com

About Celularity:
Celularity, headquartered in Warren, N.J., is a clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies derived from the postpartum human placenta. Using proprietary technology in combination with its IMPACT™ platform, Celularity is the only company harnessing the purity and versatility of placental-derived cells to develop and manufacture innovative and highly scalable off-the-shelf treatments for patients with cancer, inflammatory and age-related diseases. To learn more, please visit www.celularity.com.

Forward-Looking Statements:
This press release contains forward-looking statements. These forward-looking statements are based on expectations and are subject to certain factors, risks, and uncertainties that may cause actual results, the outcome of events, timing and performance to differ materially from those expressed or implied by such statements. The information contained in this press release is believed to be current as of the date of the original issue. Celularity expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

SOURCE Celularity, Inc.

Celularity Announces FDA Clearance of Landmark IND for CYNK-001, an Allogeneic, Off-the-Shelf Cryopreserved NK Cell Therapy

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WARREN, N.J.–(BUSINESS WIRE)–Celularity, Inc. (“Celularity” or the “Company”), a clinical-stage company developing allogeneic cellular therapies from human placentas, today announced the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) Application for CYNK-001 in patients with glioblastoma multiforme (GBM).

The clinical investigation of CYNK-001 in patients with GBM is expected to be the first clinical trial in the U.S. to investigate intratumoral administration of an allogeneic NK cell therapy. The Company plans to initiate first-in-human clinical testing of CYNK-001 administered either intravenously or intratumorally. This study is expected to evaluate the safety, feasibility, and tolerability of multiple doses of CYNK-001 in subjects with relapsed GBM.

“The FDA clearance of our IND validates the versatility of our allogeneic, off-the-shelf, placental-derived NK cell therapy platform to generate novel clinical candidates against a broad range of devastating cancers. This IND represents a significant step toward a potential immunotherapy option that is more accessible and tolerable to patients with glioblastoma multiforme,” said Robert Hariri, M.D., Ph.D., Founder, Chairman and CEO at Celularity. “We will continue to work diligently to advance our investigational and development programs, and to deliver the next-generation of scalable, high quality immunologic approaches for the treatment of devastating cancers.”

Nonclinical safety and efficacy data presented at the 2019 Society for Neuro-Oncology (SNO) Annual Meeting, demonstrated that a single administration of CYNK-001 was well-tolerated and showed enhanced in vivo anti-tumor activity against glioblastoma multiforme (GBM). CYNK-001 is currently being investigated as a treatment for acute myeloid leukemia (AML), multiple myeloma (MM), and as a potential treatment option for various solid tumors.

About CYNK-001
CYNK-001 is the only cryopreserved allogeneic, off-the-shelf NK cell therapy being developed from placental hematopoietic stem cells as a potential treatment option for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. NK cells derived from the placenta are intrinsically safe and versatile, allowing potential uses across a range of organs and tissues.

About Celularity
Celularity, headquartered in Warren, N.J., is a clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies derived from the postpartum human placenta. Using proprietary technology in combination with its IMPACT™ platform, Celularity is the only company harnessing the purity and versatility of placental-derived cells to develop and manufacture innovative and highly scalable off-the-shelf treatments for patients with cancer, inflammatory and age-related diseases. To learn more, please visit www.celularity.com.

Forward-Looking Statements
This press release contains forward-looking statements. These forward-looking statements are based on expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. The information contained in this press release is believed to be current as of the date of original issue. Celularity expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Celularity Presents Pre-Clinical and Clinical Data from its Allogeneic, Placental-Derived, Off-the-Shelf Cell Therapy Platform at the 2019 ASH Annual Meeting

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WARREN, N.J.–(BUSINESS WIRE)–Celularity, Inc. (“Celularity”), a clinical-stage cell therapeutics company focused on the development of innovative allogeneic cellular therapies derived from post partum human placentas, announced data introducing an extensive platform in genetically-modified NK- and T cell-based programs, and highlighting long-term safety and efficacy results from the Phase 1 study of PNK-007 in patients with multiple myeloma (MM). These data were announced at the 61st American Society of Hematology (ASH) Annual Meeting in Orlando, F.L.

In pre-clinical studies, Celularity’s allogeneic, placental-derived CD19 CAR T cell-based product candidate demonstrated in vivo anti-tumor efficacy in a lymphoma tumor model. Additionally, the Company’s CD38 CAR NK cell-based product candidate showed in vitro and in vivo anti-tumor activity against CD38+ lymphoma and multiple myeloma cell lines without any on-target, off-tumor effect. Moreover, the Company’s allogeneic, placental CD34+ cell-derived NK product candidate overexpressing a CD16 variant demonstrated its versatile combination potential with monoclonal antibodies to elicit in vitro and in vivo enhanced antibody-dependent cell mediated cytotoxicity (ADCC) function against lymphoma cell lines.

Results from a Phase 1 clinical study evaluating PNK-007 in patients with multiple myeloma demonstrated a single infusion of PNK-007 was well tolerated after autologous stem cell transplant (ASCT) for up to one year. PNK-007 is a first-generation investigational allogeneic off-the-shelf NK cell therapy. No serious adverse events (AEs) were attributable to PNK‐007, and no dose-limiting toxicity, graft-verse-host disease (GvHD), cytokine release syndrome (CRS), graft failure or graft rejection was observed.

“We are excited about the pre-clinical and clinical findings presented at ASH this year which adds to a growing body of evidence about the range and versatility of our allogeneic, off-the-shelf, placental-derived cell therapy platform, and its potential uses against a range of devastating cancers which today have limited treatment options,” said Robert Hariri, M.D., Ph.D., Founder, Chairman and CEO at Celularity. “At Celularity we believe the next evolution in immunotherapy for cancer demands scalable, high quality and economical solutions which provide fully allogeneic, off-the-shelf products. The Celularity technology platform can provide that solution. We look forward to rapidly advancing multiple placental-derived NK- and T cell-based product candidates with potential as more tolerable, more accessible immunotherapies.”

About PNK-007

PNK‐007 is the only allogeneic, off-the-shelf NK cell therapy being developed from placental hematopoietic stem cells as a potential treatment option for various hematologic cancers and solid tumors. NK cells are a unique class of immune cells, innately capable of targeting cancer cells and interacting with adaptive immunity. When derived from the placenta, these cells offer intrinsic safety and versatility, allowing potential use across a range of organs and tissues. PNK cells are currently being investigated as a treatment for acute myeloid leukemia (AML) and multiple myeloma (MM).

About Celularity

Celularity, headquartered in Warren, New Jersey, is a clinical-stage cell therapeutics company delivering transformative allogeneic cellular therapies, engineered from the postpartum human placenta. Using proprietary technology in combination with its IMPACT™ platform, Celularity is the only company harnessing the purity and versatility of placental derived cells to develop and manufacture innovative, highly scalable off-the-shelf treatments for patients with cancer, inflammatory and age-related diseases. To learn more, please visit www.celularity.com.

Forward-Looking Statements

This press release contains forward-looking statements. These forward-looking statements are based on expectations and are subject to certain factors, risks and uncertainties that may cause actual results, outcome of events, timing and performance to differ materially from those expressed or implied by such statements. The information contained in this press release is believed to be current as of the date of original issue. Celularity expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Contacts

Investors
John R. Haines
EVP & Chief Administrative Officer
john.haines@celularity.com

Media
Sheryl Seapy
W2O Group
sseapy@w2ogroup.com